Health management devices and methods

Abstract

Methods and devices and systems including a data collection module for receiving and storing analyte data over a predetermined time period from a subject, a user interface unit coupled to the data collection module for providing one or more indication related to the analyte data, a control unit coupled to the data collection module and the user interface unit to control, at least in part the operation of the data collection module and the user interface unit, a communication module coupled to the control unit for communicating one or more signals associated with the analyte data to a remote location, where the user interface unit is configured to operate in a prospective analysis mode including substantially real time output of the analyte level received by the data collection module, and a retrospective analysis mode including limited output of information to the subject during the predetermined time period, and further where the communication module is configured to communicate with the remote location after the analyte data is received and stored in the data collection module over the predetermined time period, are provided.

What is claimed is: 
     
       1. An analyte monitoring device, comprising:
 a data collection module for receiving and storing analyte data over a predetermined time period; 
 a user interface unit coupled to the data collection module for providing one or more indication related to the analyte data; 
 a control unit coupled to the data collection module and the user interface unit, and configured to control, at least in part an operation of the data collection module and the user interface unit; and 
 a communication module coupled to the control unit for communicating one or more signals associated with the analyte data to a remote location;
 wherein the user interface unit is configured to operate in a prospective analysis mode including substantially real time output of an analyte level received by the data collection module, and a retrospective analysis mode including limited output of information during the predetermined time period; 
 wherein the communication module is configured to communicate with the remote location after the analyte data is received and stored in the data collection module over the predetermined time period; and 
 wherein the data collection module is operatively coupled to a transcutaneously positioned analyte sensor in fluid contact with an interstitial fluid under a skin layer, the analyte sensor generating signals corresponding to a monitored analyte level over the predetermined time period, wherein when the user interface unit is operating in the retrospective analysis mode, the user interface unit is configured to not display any information related to the received analyte data during the predetermined time period. 
 
 
     
     
       2. The device of  claim 1  wherein the communication module is configured to communicate with the remote location using one or more of a USB cable connection, a serial cable connection, a radio frequency (RF) communication protocol, an infrared communication protocol, a Bluetooth communication protocol, or an 802.11x communication protocol. 
     
     
       3. The device of  claim 1  wherein the limited output of information during the retrospective analysis mode includes output to the user interface unit of one or more of the analyte monitoring device operational status information, a time of day information, a user profile information, or an elapsed duration of the predetermined time period. 
     
     
       4. The device of  claim 1  wherein the data collection module includes one or more of a data storage device or a memory device. 
     
     
       5. The device of  claim 1  wherein the data collection module is configured to delete the stored analyte data after transferring the analyte data to the remote location. 
     
     
       6. The device of  claim 1  wherein the remote location includes a data processing terminal. 
     
     
       7. The device of  claim 1  wherein during the prospective analysis mode, the user interface unit is configured to visually output real time information related to the received analyte data. 
     
     
       8. The device of  claim 7  wherein the visual output includes one or more of a graphical output, a numerical output, or a text output. 
     
     
       9. The device of  claim 1  wherein the stored analyte data in the data collection module are uncalibrated. 
     
     
       10. The device of  claim 1  wherein the communicated one or more signals associated with the analyte data to the remote location includes uncalibrated analyte data. 
     
     
       11. The device of  claim 1  wherein the communication module is configured to receive one or more calibration information. 
     
     
       12. The device of  claim 11  wherein the calibration information includes blood glucose data. 
     
     
       13. The device of  claim 11  wherein the control unit is configured to calibrate the received and stored analyte data based on the received calibration information to generate calibrated analyte data. 
     
     
       14. The device of  claim 13  wherein the data collection module is configured to store the calibrated analyte data. 
     
     
       15. The device of  claim 13  wherein the communication module is configured to transmit the calibrated analyte data to the remote location. 
     
     
       16. The device of  claim 1  wherein the analyte sensor comprises a plurality of electrodes including a working electrode, and further wherein the working electrode comprises an analyte-responsive enzyme and a mediator. 
     
     
       17. The device of  claim 16  wherein at least one of the analyte-responsive enzyme and the mediator is chemically bonded to a polymer disposed on the working electrode. 
     
     
       18. The device of  claim 17  wherein at least one of the analyte-responsive enzyme and the mediator is crosslinked with the polymer. 
     
     
       19. A method, comprising:
 transcutaneously positioning an analyte sensor in fluid contact with interstitial fluid under a skin layer; 
 generating analyte data based on signals from the analyte sensor, the analyte data corresponding to a monitored analyte level over a predetermined time period; 
 storing the analyte data corresponding to the monitored analyte level over the predetermined time period; 
 providing one or more indication related to the analyte data on a user interface unit, including operating the user interface unit in a prospective analysis mode including substantially real time output of the monitored analyte level, and a retrospective analysis mode including limited output of information during the predetermined time period; and 
 communicating one or more signals associated with the analyte data to a remote location after the analyte data is generated and stored over the predetermined time period;
 wherein when the user interface unit is operating in the retrospective analysis mode, the user interface unit is configured to not display any information related to the received analyte data during the predetermined time period. 
 
 
     
     
       20. The method of  claim 19  including communicating with the remote location using one or more of a USB cable connection, a serial cable connection, a radio frequency (RF) communication protocol, an infrared communication protocol, a Bluetooth communication protocol, or an 802.11x communication protocol. 
     
     
       21. The method of  claim 19  wherein the limited output of information during the retrospective analysis mode includes outputting one or more of an operational status information, a time of day information, a user profile information, or an elapsed duration of the predetermined time period. 
     
     
       22. The method of  claim 19  including deleting the stored analyte data after transferring the analyte data to the remote location. 
     
     
       23. The method of  claim 19  including, during the prospective analysis mode, visually outputting real time information related to the analyte data. 
     
     
       24. The method of  claim 23  wherein the visual output includes one or more of a graphical output, a numerical output, or a text output. 
     
     
       25. The method of  claim 19  wherein the stored analyte data are uncalibrated. 
     
     
       26. The method of  claim 19  including transmitting uncalibrated analyte data to the remote location. 
     
     
       27. The method of  claim 19  including receiving one or more calibration information. 
     
     
       28. The method of  claim 27  including calibrating the generated and stored analyte data based on the received calibration information to generate calibrated analyte data. 
     
     
       29. The method of  claim 28  including storing the calibrated analyte data. 
     
     
       30. The method of  claim 28  including transmitting the calibrated analyte data to the remote location. 
     
     
       31. The method of  claim 19  wherein the analyte sensor comprises a plurality of electrodes including a working electrode, and further wherein the working electrode comprises an analyte-responsive enzyme and a mediator. 
     
     
       32. The method of  claim 31  wherein at least one of the analyte-responsive enzyme and the mediator is chemically bonded to a polymer disposed on the working electrode. 
     
     
       33. The method of  claim 32  wherein at least one of the analyte-responsive enzyme and the mediator is crosslinked with the polymer.